This invention relates generally to medicament containers/dispensers such as intravenous bags, bottles or the like, more particularly, is directed to such devices as are prepared and used for the intravenous delivery of medicaments in pre-measured dosages.
It is estimated that over 675 million intravenous (IV) containers are sold, and that about 240 million intravenous (IV) unit doses of various medicaments or drugs are given annually in the United States. In the past, most of these doses have been prepared under sterile conditions in hospital pharmacies. Recently, however, a number of pharmaceutical manufacturers have been producing and selling some of the more popular drugs in small pre-mixed IV bags, typically in sizes of 50 cc and 100 cc. Because of the overall labor savings, economy and ease of use, these products have gained in popularity, and sales thereof have increased dramatically.
Generally, the pliable IV bags are difficult to manipulate when full, while the rigid glass IV bottles are undesirably breakable. Further, although the IV bags are generally suitable for drugs which are stable at room temperature when pre-mixed, unstable drugs cannot be contained in pre-mixed forms in such IV bags. To overcome this problem, some of these products are being packaged and sold in frozen form, or alternatively, in a double bag configuration in which the contents of one IV bag can be released into the contents of the other IV bag to mix the components at a subsequent time. As will be appreciated, such double bag configuration is relatively expensive and cumbersome to manufacture and use. In an alternative system, the IV bag is provided with a vial port for receiving a drug containing vial which is screwed thereinto. This IV bag with a separately packaged drug vial also is relatively expensive and cumbersome to use.
U.S. Pat. No. 3,059,643 to Barton discloses an arrangement in which a first bottle is provided with a resealable elastic membrane. Another bottle has a bottle adapter with a conduit having a spike at the end, which can be used to puncture the resealable membrane of the first bottle to mix the contents of the two bottles. See also U.S. Pat. No. 4,475,914 to Portnoff. These Patents are particularly useful when mixing unstable drugs.
U.S. Pat. No. 2,275,567 to Smith discloses an arrangement in which an assembly is provided at an inlet of the container, the assembly including a capsule. A rod is positioned in the assembly immediately above the capsule and when depressed, crushes the capsule to release the contents thereof into the contents already in the container, so as to mix the two drugs. However, in this arrangement, the fragments of the capsule also fall into the liquid, and may contaminate the same or obstruct any exit of the mixed drug from the container. In a similar context, U.S. Pat. No. 2,854,977 to McConnaughey discloses an elongated tube with a tapering nozzle, such tube being disposed with flexible walls permitting compression to rupture the capsules therein. The deficiencies of this arrangement are the same as with Smith.
Another problem with the above IV bags, and with other conventional IV bags, is that of pressure equalization. More particularly, because the IV bags are hermetically sealed, a reduction in internal pressure develops as the liquid medicament flows from the IV bag. This change in pressure may have an effect on the rate of flow of the liquid medicament from the IV bag. Thus, the patient may not receive the proper dosage of the drug.
In this regard, U.S. Pat. No. 3,193,993 to Barton et al. discloses a partially rigid bottle with a semi-permeable membrane provided for the equalization of internal pressure with the external atmosphere. This is provided because the container is only slight deformable or collapsible, and it is therefore necessary to provide for the entry of air to permit the contents to flow out through the administration set. In this Patent, a side wall of the container is provided with an indented area, and a disc of resealing rubbery material is affixed to the indented area and provides for the insertion of the spike of an air inlet and filter device for such pressure equalization. The Barton et al. device suffers from two deficiencies in that this container is undesirably opaque, and extensive effort and cost is expended in attempting to make it sufficiently transparent, and the filling and sterilizing procedure is difficult to accomplish owing to the risk of container deformation.
U.S. Pat. No. 4,356,012 to Hofstetter relates to urinary drainage containers. With this Patent, a vent opening is provided and a hydrophobic filter which permits the exit of air from the bag but does not permit liquid to pass through the filter, is sealed against an inner surface of the container. The filter is sealed to the container or bag wall by two anchoring areas, each of which is of a rectangular shape and which extends about the periphery of an area of the container wall defining the vent openings. The purpose of such vent openings, however, is to vent air from the urinary drainage bag to permit the bag to become filled with urine.